Ejaculatory Sparing vs. Non-ejaculatory Sparing GreenLightTM Laser Photoselective Vaporization of the Prostate (PVP): A Randomized Double Blind Sexual and Urodynamic Assessment
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- ejaculatory function
研究概览
简要总结
GreenLight laser PVP currently gains wide acceptance as a minimally invasive treatment for benign prostate enlargment and the emergence of ejaculatory sparing techniques made it feasible to get both benefits: relief of lower urinary tract symptoms and preservation of ejaculation. However evaluation of actual infravesical de-obstruction following such techniques remains a grey zone in the literature without an objective assessment of the degree of de-obstruction. Furthermore, the impact of maintaining ejaculation on different domains of the sexual function using comprehensive assessment tools was not compared in ejaculatory sparring vs. non-ejaculatory sparring approaches.
详细描述
I- Introduction:
Benign prostatic enlargement is one of the most prevalent disorders in aging men and may develop into benign prostatic obstruction (BPO) causing a significant effect on the quality of life (QoL). Clinical manifestations of BPO include a variety of lower urinary tract symptoms (LUTS) that can be classified into voiding symptoms or storage symptoms.
Laser prostatectomy includes two major technical principles; enucleation of the adenoma from the surrounding capsule or laser ablation of the adenoma. GreenLight laser (532-nm laser) and Holmium: Yttrium-Aluminum-Aarnet (Ho:YAG) laser (2100 nm) are commonly used nowadays. However, TURP remains the gold standard modality of treatment.
Ejaculation is one of the fundamental domains of male sexual functions. It is well established that ejaculation disturbances, either anejaculation or loss of antegrade ejaculation, are almost inevitable adverse effects of prostate surgery especially TURP. A problem which also associates prolonged use of α-adrenoreceptros blockers. Such adverse event can be the reason why patients may choose to avoid surgical treatment.
This ejaculatory dysfunction can be attributed, according to current theory of ejaculation, to the loss of bladder neck function after resection. However, many recent studies demonstrated that bladder neck closure may not have such important role in maintaining antegrade ejaculation. Recent techniques had been developed to preserve ejaculation including ejaculatory hood sparing technique, prostatic urethral lift and the Rezum System ( convective water vapor energy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •To be eligible in the study, patient must fulfill the following criteria:
- •Age ≥ 50 years
- •ASA (American society of anesthesiologists) score ≤
- •TRUS estimated prostate weight 30-80 grams.
- •Sexually interested and having continuous relationship with the same partner (interested).
- •BOOI (bladder outlet obstructing index) ≥ 20 as per pressure flow study
排除标准
- •Patients with any of the following are to be excluded:
- •Preoperative sexual or ejaculatory disturbances or pelvic pain syndrome
- •Documented or suspected prostate cancer (significantly elevated PSA, positive biopsy for prostate cancer guided by TRUS)
- •Neurological disorders that can affect potency and ejaculation e.g. long standing uncontrolled DM (> 10 years) cerebral stroke, Parkinsonism
- •Active urinary tract infection
- •Urodynamic changes consistent with urethropathy or detrusor hypocontractility
- •Previous pelvic surgeries
- •History of pelvic radiotherapy
结局指标
主要结局
ejaculatory function
时间窗: 4 months
the ability to maintain ejaculatory function as depicted by Ej-MSHQ score
次要结局
- International index of erectile function-15(4 months)
- Bladder outlet obstruction index(4 months)